Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000635167
Ethics application status
Approved
Date submitted
17/04/2019
Date registered
30/04/2019
Date last updated
21/10/2021
Date data sharing statement initially provided
30/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cancer patients experiences of psychosocial care: An intervention to improve the quality of psychosocial care
Scientific title
Improving and maintaining the quality of psychosocial care provided to cancer patients: A systems-based intervention study incorporating audit and feedback.
Secondary ID [1] 296671 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 310513 0
Condition category
Condition code
Cancer 309226 309226 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A systems-based approach will be used with the aim of improving the quality of psychosocial care provided to cancer patients. Using a multiple baseline design, cancer clinics will receive online or written monthly feedback over a 12 month period from the research team on patient experiences of care over the previous month and asked to set targets for improvement. The feedback will be data on patient's experiences of care across a number of psychosocial domains. For example, the proportion of patients who report that they were asked about pain or fatigue at their last visit. If this proportion is considered sub-optimal (ie, below 75%), the clinic will be asked to set a performance target over the next data collection period (eg an improvement from 70% to 75%). A stepped approach will be used whereby the intervention will "step-up" if improvements are not detected after a period of 3 months. Written/electronic feedback will be supplied as the first step, with visits from a cancer services director to the clinic to discuss feedback and devise strategies to improve care as needed.
Intervention code [1] 312983 0
Behaviour
Intervention code [2] 314296 0
Treatment: Other
Comparator / control treatment
Each participating site will act as its own control. A baseline period of 8 weeks of data collection will provide control (or usual care) data, prior to the intervention commencing. Usual care is defined as the care provided by the clinic on an average day in the absence of any quality improvement strategies.
Control group
Active

Outcomes
Primary outcome [1] 308194 0
Patient experiences of care as assessed by the project-specific System for Patient Assessment of Cancer Experiences (SPACE)
Timepoint [1] 308194 0
Baseline, monthly during the intervention period, and 12 months following baseline.
Secondary outcome [1] 354210 0
Health related quality of Life as measured by the SF-12v2
Timepoint [1] 354210 0
Baseline, monthly during the intervention period, and 12 months following baseline.
Secondary outcome [2] 354211 0
Depression, as measured by the Hospital Anxiety and Depression Scale (HADS).
Timepoint [2] 354211 0
Baseline, monthly during the intervention period, and 12 months following baseline.
Secondary outcome [3] 369733 0
Anxiety, as measured by the Hospital Anxiety and Depression Scale (HADS).
Timepoint [3] 369733 0
Baseline, monthly during the intervention period, and 12 months following baseline.

Eligibility
Key inclusion criteria
Aged 18 or over, attending a participating cancer clinic for an outpatient clinic appointment or to receive treatment as an outpatient, have a confirmed diagnosis of cancer (any type), English-speaking, able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent, under 18 years of age, no confirmed diagnosis of cancer, unable to complete a survey in English, too unwell on day of recruitment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Multiple baseline design. Only participants recruited during the intervention and follow-up phases will be subject to the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be an interrupted time series study within site. The change in trend for composite experience of care outcome will be assessed using linear regression. The linear regression model will include terms for time (pre-, during, and post-intervention), phase (baseline, during, or intervention), and the interaction of time and phase to allow for change in the direction of effect.
The secondary analysis will be a pre vs post analysis within each site. The change in proportions of patients with anxiety, and patients with depression, at each site will be assessed from pre- to post- intervention using logistic regression. The change in quality of life outcome will be assessed from pre- to post- intervention using linear regression.
SAS 9.4 will be used to conduct the analysis.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
COVID-19 interruptions.
Date of first participant enrolment
Anticipated
Actual
23/04/2019
Date of last participant enrolment
Anticipated
1/07/2021
Actual
10/02/2020
Date of last data collection
Anticipated
1/07/2021
Actual
10/02/2020
Sample size
Target
9600
Accrual to date
Final
1287
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12483 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 12484 0
Gosford Hospital - Gosford
Recruitment hospital [3] 12485 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [4] 12486 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [5] 12487 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [6] 12488 0
Armidale Rural Referral Hospital - Armidale
Recruitment postcode(s) [1] 24805 0
2298 - Waratah
Recruitment postcode(s) [2] 24806 0
2250 - Gosford
Recruitment postcode(s) [3] 24807 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [4] 24808 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 24809 0
2340 - Tamworth
Recruitment postcode(s) [6] 24810 0
2350 - Armidale

Funding & Sponsors
Funding source category [1] 301251 0
Charities/Societies/Foundations
Name [1] 301251 0
Cancer Council NSW
Country [1] 301251 0
Australia
Primary sponsor type
Individual
Name
Rob Sanson-Fisher
Address
W4, HMRI Building
University of Newcastle
University Drive
Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 300885 0
None
Name [1] 300885 0
Address [1] 300885 0
Country [1] 300885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301989 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301989 0
Ethics committee country [1] 301989 0
Australia
Date submitted for ethics approval [1] 301989 0
Approval date [1] 301989 0
16/07/2018
Ethics approval number [1] 301989 0
18/06/20/5.10
Ethics committee name [2] 301993 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 301993 0
Ethics committee country [2] 301993 0
Australia
Date submitted for ethics approval [2] 301993 0
Approval date [2] 301993 0
02/11/2018
Ethics approval number [2] 301993 0
H-2018-0449

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88782 0
Prof Rob Sanson-Fisher
Address 88782 0
Health Behaviour Research Collaborative
W4, HMRI Building
University of Newcastle
University Drive
Callaghan, NSW, 2308
Country 88782 0
Australia
Phone 88782 0
+61 2 4042 0713
Fax 88782 0
Email 88782 0
[email protected]
Contact person for public queries
Name 88783 0
Rob Sanson-Fisher
Address 88783 0
Health Behaviour Research Collaborative
W4, HMRI Building
University of Newcastle
University Drive
Callaghan, NSW, 2308
Country 88783 0
Australia
Phone 88783 0
+61 2 4042 0713
Fax 88783 0
Email 88783 0
[email protected]
Contact person for scientific queries
Name 88784 0
Rob Sanson-Fisher
Address 88784 0
Health Behaviour Research Collaborative
W4, HMRI Building
University of Newcastle
University Drive
Callaghan, NSW, 2308
Country 88784 0
Australia
Phone 88784 0
+61 2 4042 0713
Fax 88784 0
Email 88784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics approval to share individual data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.